Visit Drugs@FDA to search Drug Approval Reports by Month.ÂÂ
October 06, 2010
- Aridol (mannitol) Inhalation Powder, Pharmaxis, Inc., Approval
- Eligard (leuprolide acetate) Injectable Suspension, sanofi-aventis, Labeling Revision
October 05, 2010
- Atomoxetine Hydrochloride Capsules, TEVA Pharmaceuticals, Approval
- Carbidopa, Levodopa and Entacapone Tablets, Sun Pharmaceutical, Tentative Approval
- COMBIVIR (lamivudine/zidovudine) Tablets, GlaxoSmithKline, Labeling Revision
- DURAMORPH (morphine sulfate) Injection, Baxter HealthCare Corporation, Labeling Revision
- Levetiracetam Oral Solution, Tris Pharma, Inc., Approval
- Mycophenolate Mofetil Hydrochloride Injection, Bedford Laboratories, Tentative Approval
- VIREAD (tenofovir disoproxil fumarate) Tablets, Gilead Sciences Inc., Efficacy Supplement
October 4, 2010
- Clopidogrel Bisulfate Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
- Naphazoline Hydrochloride and Pheniramine Maleate Ophthalmic Solution, Altaire Pharmaceuticals, Inc., Approval
- Opana ER (oxymorphone hydrochloride) Tablets, Endo Pharmaceuticals, Inc., Labeling Revision
- Procardia XL (nifedipine) Extended-Release Tablets, Pfizer, Inc., Labeling Revision
- Proscar (finasteride) Tablets, Altaire Pharmaceuticals, Inc., Labeling Revision
September 30, 2010
- Abacavir Sulfate Tablets, InvaGen Pharmaceuticals, Inc., Tentative Approval
- Altabax (retapamulin) Ointment, GlaxoSmithKline, Labeling Revision
- Jenloga (clonidine hydrochloride) Tablets, Shionogi Pharma, Inc., Labeling Revision
- Kapvay (clonidine hydrochloride) Extended-Release Tablets, Shionogi Pharma, Inc., Efficacy Supplement
- Peridex (chlorhexidine gluconate) Solution, 3M ESPE Dental Products, Manufacturing Supplement
- Prilocaine Hydrochloride Injection, Arent Fox LLP, Approval
- Rosuvastatin Calcium Tablets, Sun Pharma, Tentative ApprovalÂÂ
September 29, 2010
- Beyaz (drospirenone, ethinyl estradiol and levomefolate calcium) Tablets, Bayer HealthCare Pharmaceuticals Inc., Approval
- Buprenorphine Hydrochloride Sublingual Tablets, Ethypharm USA Corporation, Approval
- Clopidogrel Tablets, Torrent Pharmaceuticals Limited, Tentative Approval
- Duetact (glimepiride and pioglitazone hydrochloride) Tablets, Takeda Global Research Development Center, Inc., Labeling Revision
- Janumet (metformin hydrochloride and sitagliptin phosphate) Tablets, Merck Sharp and Dohme Corp., Labeling Revision
- Januvia (sitagliptin phosphate) Tablets, Merck Sharp and Dohme Corp., Labeling RevisionÂÂ
- Ozurdex (dexamethasone) Intravitreal Implant, Allergan, Inc., Efficacy Supplement with Clinical Data to Support
- Ranexa (ranolazine) Extended-Release Tablets, Gilead Sciences, Inc., Labeling Revision
- Zofran (ondansetron hydrochloride) Injection, GlaxoSmithKline, Labeling Revision
- Zofran and Dextrose in Plastic Container (ondansetron hydrochloride) Injection Premixed, GlaxoSmithKline, Labeling RevisionÂÂ
September 28, 2010
- Fludarabine Phosphate Injection, Bioniche Pharma USA LLC, Approval
- Introvale (ethinyl estradiol and levonorgestrel) Tablets, Sandoz Inc., Approval
- Lidocaine Hydrochloride Preservative Free Injection, Strides Arcolab Ltd., Approval
- Lopid Tablets, Pfizer, Inc., Labeling Revision
- Oraqix (lidocaine and prilocaine) Gel, Dentsply Pharmaceutical, Inc., Labeling Revision
- Oxymorphone Hydrochloride Tablets, Roxane Laboratories, Inc., Approval
- Riluzole Tablets, Sun Pharmaceutical Industries, Ltd., Tentative Approval
September 24, 2010
- Famciclovir Tablets, Watson Laboratories, Inc., Tentative Approval
- Zofran (ondansetron hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
- Zofran (ondansetron hydrochloride) Oral Solution, GlaxoSmithKline, Labeling Revision
- Zofran ODT (ondansetron) Orally Disintegrating Tablets, GlaxoSmithKline, Labeling Revision
September 23, 2010
- Alli (orlistat) Capsules, GlaxoSmithKline Consumer, Labeling Revision
- Cozaar (losartan potassium) Tablets, Merck and Company, Labeling Revision
- Gilenya (fingolimod) Capsules, Novartis Pharmaceutical Corporation, ApprovalÂÂ
- Granisetron Hydrochloride Injection, Luitpold Pharmaceuticals, Inc., Approval
- Hyzaar (losartan potassium and hydrochlorothiazide) Tablets, Merck and Company, Labeling RevisionÂÂ
- Lialda (mesalamine) Delayed-Release Tablet, Shire Development Inc., Labeling Revision  ÂÂ
September 22, 2010
- Alprazolam Tablets, Boca Pharmacal, Inc., Approval
- Asmanex Twisthaler (mometasone furoate) Inhalation Powder, Schering-Plough Corporation, Approval
- Atomoxetine Hydrochloride Capsules, Zydus Pharmaceuticals, Approval
- Atazanavir Sulfate Capsules, Matrix Laboratories Ltd., Tentative Approval
- Casodex (bicalutamide) Tablets, AstraZeneca Pharmaceuticals, Labeling Revision
- Duloxetine Hydrochloride Delayed-Release Capsules, Zydus Pharmaceuticals, Tentative Approval
- Fosinopril Sodium and Hydrochlorothiazide Tablets, Actavis Totowa LLC, ApprovalÂÂ
- Gemfibrozil Tablets, Northstar Healthcare Holdings Ltd., ApprovalÂÂ
- Nifedipine Extended-Release Tablets, Matrix Laboratories Ltd., Approval
- Nizoral A-D (ketoconazole) Shampoo, McNeil Consumer Healthcare, ApprovalÂÂ
- Rifampin Injection, Covenant Pharma, Inc., ApprovalÂÂ
- Tacrolimus Capsules, Mylan Pharmaceuticals, Inc., Approval ÂÂ
September 20, 2010
- Ampicillin and Sulbactam Injection, Aurobindo Pharma Ltd., Approval
- Ampicillin and Sulbactam Injection, Aurobindo Pharma Ltd., Approval
- Ampicillin and Sulbactam Injection, Aurobindo Pharma Ltd., Approval
- Zyban (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision
September 17, 2010
- Benzphetamine Hydrochloride Tablets, Mikart, Inc., Approval
- Colgate Total (sodium fluoride and triclosan) Dental Paste, Colgate-Palmolive Co., Efficacy Supplement with Clinical Data to Support
- Krystexxa (pegloticase) Injection, Savient Pharmaceuticals, Inc., Approval
- Minocin (minocycline hydrochloride) Injection, Triax Pharmaceuticals, Inc., Labeling Revision
- Prevacid 24 HR (lansoprazole) Delayed-Release Capsules, Novartis Consumer Health, Inc., Labeling Revision
- Zarontin (ethosuximide) Capsules, Pfizer, Inc., Labeling Revision
September 16, 2010
- Duloxetine Hydrochloride Delayed-Release Capsules, Torrent Pharmaceuticals Ltd., Tentative Approval
- Minocin (minocycline hydrochloride) Capsules, Triax Pharmaceuticals, Inc., Labeling Revision
- Minocin (minocycline hydrochloride) Oral Suspension, Triax Pharmaceuticals, Inc., Labeling Revision
- Mycophenolate Mofetil Tablets, Dr. Reddy’s Laboratories Ltd., Approval
- Trilipix (choline fenofibric) Delayed-Release Capsules, Abbott Laboratories, Labeling Revision
- Welchol (colesevelam hydrochloride) Oral Suspension, Daiichi Sankyo, Inc., Labeling Revision
- Welchol (colesevelam hydrochloride) Tablets, Daiichi Sankyo, Inc., Labeling Revision
September 14, 2010
- Atomoxetine Hydrochloride Capsules, Aurobindo Pharma Ltd., Approval
- Atomoxetine Hydrochloride Capsules, Sandoz, Inc., ApprovalÂÂ
- Augmentin XR (amoxicillin and clavulanate potassium) Extended Release Tablets, GlaxoSmithKline, Labeling RevisionÂÂ
- Methylergonovine Maleate Injection, ErgoJect, LLC, Approval
- Mycophenolate Mofetil Tablets, Dr. Reddy’s Laboratories Ltd., Approval
- Nifedipine Extended-Release Tablets, Matrix Laboratories Ltd., Approval
- Norethindrone, Ethinyl Estradiol and Ferrous Fumarate Chewable Tablets, Watson Laboratories, Inc., Tentative ApprovalÂÂ
- Pantoprazole Sodium Delayed Release Tablets, Torrent Pharmaceuticals Ltd., Tentative ApprovalÂÂ
- Prednisolone Sodium Phosphate Oral Solution, Pharmaceutical Associates, Inc., Approval
- Salonpas Patch, Pharmaceutical Development Group, Manufacturing Change or Addition
- Suboxone (buprenorphine and naloxone) Oral Soluble Film, Reckitt Benckiser Pharmaceuticals Inc., Labeling Revision ÂÂ
   ÂÂ